Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02811159
Recruitment Status : Terminated (Business decision)
First Posted : June 23, 2016
Results First Posted : June 19, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Uterine Fibroids
Intervention Drug: Telapristone acetate
Enrollment 20
Recruitment Details  
Pre-assignment Details Participants who had successfully completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897] were enrolled in this study.
Arm/Group Title Telapristone Acetate 12 mg
Hide Arm/Group Description Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
Period Title: Treatment Course 1
Started 20
Completed 19
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Period Title: Treatment Course 2
Started 4 [1]
Completed 4
Not Completed 0
[1]
Not all participants who completed the Treatment Course 1 entered the Treatment Course 2.
Arm/Group Title Telapristone Acetate 12 mg
Hide Arm/Group Description Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Safety population included all study participants who were randomized, received study drug and had some post-baseline safety data.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
43.3  (3.62)
[1]
Measure Analysis Population Description: Safety population included all study participants who were randomized, received study drug and had some post-baseline safety data.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
20
 100.0%
Male
0
   0.0%
[1]
Measure Analysis Population Description: Safety population included all study participants who were randomized, received study drug and had some post-baseline safety data.
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Percentage of Participants in Amenorrhea
Hide Description Amenorrhea was defined as no bleeding intensity score greater than 1 using the Daily Diary Card during the 28 days leading up to the last day of dosing at Week 18. Bleeding intensity was graded on a 5-point scale where: 0=no bleeding to 4=heavy bleeding.
Time Frame At the end of 18 weeks Treatment Course 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all participants who received study drug.
Arm/Group Title Telapristone Acetate 12 mg
Hide Arm/Group Description:
Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
35.00
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telapristone Acetate 12 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1797
Comments [Not Specified]
Method Chi-Square Test
Comments [Not Specified]
2.Primary Outcome
Title Percentage Change From Baseline in Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score
Hide Description UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. Each question was answered on a 5-point scale where 1=Not at all to 5=A very great deal. The sum of the total scores was transformed to a range of 0=no symptoms (best) to 100=most severe symptoms (worst). A negative percentage change from Baseline indicates improvement.
Time Frame Baseline to the end of 18-weeks Treatment Course 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received study drug.
Arm/Group Title Telapristone Acetate 12 mg
Hide Arm/Group Description:
Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percent change
-7.21  (20.046)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telapristone Acetate 12 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1250
Comments [Not Specified]
Method Wilcoxon Signed-Rank Test
Comments [Not Specified]
3.Primary Outcome
Title Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 1
Hide Description UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 1: During the previous 3 months how distressed were you by "heavy bleeding during your menstrual period"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Time Frame Baseline to the end of 18-weeks Treatment Course 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received study drug.
Arm/Group Title Telapristone Acetate 12 mg
Hide Arm/Group Description:
Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percent change
-10.50  (26.253)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telapristone Acetate 12 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2500
Comments [Not Specified]
Method Wilcoxon Signed-Rank Test
Comments [Not Specified]
4.Primary Outcome
Title Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 2
Hide Description UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 2: During the previous 3 months how distressed were you by "passing blood clots during your menstrual period"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Time Frame Baseline to the end of 18-weeks Treatment Course 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received study drug.
Arm/Group Title Telapristone Acetate 12 mg
Hide Arm/Group Description:
Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percent change
-5.83  (18.157)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telapristone Acetate 12 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method Wilcoxon Signed-Rank Test
Comments [Not Specified]
5.Primary Outcome
Title Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 3
Hide Description UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 3: During the previous 3 months how distressed were you by "fluctuation in the duration of your menstrual period compared to your previous cycle"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Time Frame Baseline to the end of 18-weeks Treatment Course 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received study drug.
Arm/Group Title Telapristone Acetate 12 mg
Hide Arm/Group Description:
Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percent change
-8.75  (23.333)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telapristone Acetate 12 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2500
Comments [Not Specified]
Method Wilcoxon Signed-Rank Test
Comments [Not Specified]
6.Primary Outcome
Title Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 4
Hide Description UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 4: During the previous 3 months how distressed were you by "fluctuation in the length of your monthly cycle compared to your previous cycles"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Time Frame Baseline to the end of 18-weeks Treatment Course 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received study drug.
Arm/Group Title Telapristone Acetate 12 mg
Hide Arm/Group Description:
Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percent change
-3.75  (16.771)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telapristone Acetate 12 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon Signed-Rank Test
Comments [Not Specified]
7.Primary Outcome
Title Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 5
Hide Description UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 5: During the previous 3 months how distressed were you by "feeling tightness or pressure in your pelvic area"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Time Frame Baseline to the end of 18-weeks Treatment Course 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received study drug.
Arm/Group Title Telapristone Acetate 12 mg
Hide Arm/Group Description:
Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percent change
-4.17  (33.278)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telapristone Acetate 12 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8750
Comments [Not Specified]
Method Wilcoxon Signed-Rank Test
Comments [Not Specified]
8.Primary Outcome
Title Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 6
Hide Description UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 6: During the previous 3 months how distressed were you by "frequent urination during the daytime hours"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Time Frame Baseline to the end of 18-weeks Treatment Course 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received study drug.
Arm/Group Title Telapristone Acetate 12 mg
Hide Arm/Group Description:
Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percent change
-7.33  (22.675)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telapristone Acetate 12 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method Wilcoxon Signed-Rank Test
Comments [Not Specified]
9.Primary Outcome
Title Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 7
Hide Description UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 7: During the previous 3 months how distressed were you by "frequent night time urination"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Time Frame Baseline to the end of 18-weeks Treatment Course 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received study drug.
Arm/Group Title Telapristone Acetate 12 mg
Hide Arm/Group Description:
Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percent change
6.67  (35.210)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telapristone Acetate 12 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method Wilcoxon Signed-Rank Test
Comments [Not Specified]
10.Primary Outcome
Title Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 8
Hide Description UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 8: During the previous 3 months how distressed were you by "feeling fatigued"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Time Frame Baseline to the end of 18-weeks Treatment Course 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received study drug.
Arm/Group Title Telapristone Acetate 12 mg
Hide Arm/Group Description:
Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percent change
-6.67  (16.579)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telapristone Acetate 12 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2500
Comments [Not Specified]
Method Wilcoxon Signed-Rank Test
Comments [Not Specified]
11.Primary Outcome
Title Change From Baseline in Pictorial Blood Loss Assessment Chart (PBAC) Score
Hide Description Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss. Participants recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Pictorial scores range from score 1 for slightly stained tampon/towel, 5 for a partially stained tampon/towel, 10 for a completely saturated tampon, 20 for a completely saturated towel, and 5 for each episode of flooding and for each blood clot larger than a quarter in size. Total score can range from 0 (no bleeding) to >500. Higher scores indicate more bleeding. Lower scores indicate less bleeding. A negative change from Baseline indicates improvement (reduction in bleeding).
Time Frame Baseline to the end of 18-weeks Treatment Course 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population Included all participants who received study drug.
Arm/Group Title Telapristone Acetate 12 mg
Hide Arm/Group Description:
Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 139.50  (196.111)
Change from Baseline to Week 18 Course 1 -81.10  (239.790)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telapristone Acetate 12 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0645
Comments [Not Specified]
Method Wilcoxon Signed-Rank Test
Comments [Not Specified]
12.Primary Outcome
Title Percentage Change From Baseline in Total Uterine Fibroid Volume
Hide Description The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI). A negative percentage change from Baseline indicates improvement.
Time Frame Baseline to the end of 18-weeks Treatment Course 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population Included all participants who received study drug. MRI data was only available for 3 participants.
Arm/Group Title Telapristone Acetate 12 mg
Hide Arm/Group Description:
Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: percent change
0.00  (0.000)
Time Frame From first dose of study drug through 30 days after the last dose of study drug (approximately 43 weeks)
Adverse Event Reporting Description Safety population consisted of all study participants who were randomized, received study drug and had some post-baseline safety data.
 
Arm/Group Title Telapristone Acetate 12 mg
Hide Arm/Group Description Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
All-Cause Mortality
Telapristone Acetate 12 mg
Affected / at Risk (%)
Total   0/20 (0.00%) 
Hide Serious Adverse Events
Telapristone Acetate 12 mg
Affected / at Risk (%)
Total   1/20 (5.00%) 
Investigations   
Liver function test abnormal  1  1/20 (5.00%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Telapristone Acetate 12 mg
Affected / at Risk (%)
Total   11/20 (55.00%) 
Gastrointestinal disorders   
Abdominal pain  1  1/20 (5.00%) 
Diverticulitis  1  1/20 (5.00%) 
Dyspepsia  1  1/20 (5.00%) 
Flatulence  1  1/20 (5.00%) 
Nausea  1  1/20 (5.00%) 
General disorders   
Hot flush  1  2/20 (10.00%) 
Chills  1  1/20 (5.00%) 
Fatigue  1  1/20 (5.00%) 
Infections and infestations   
Upper respiratory tract infection  1  2/20 (10.00%) 
Urinary tract infection  1  2/20 (10.00%) 
Acute sinusitis  1  1/20 (5.00%) 
Bronchitis  1  1/20 (5.00%) 
Sinusitis  1  1/20 (5.00%) 
Vulvovaginal mycotic infection  1  1/20 (5.00%) 
Investigations   
Blood cholesterol increased  1  1/20 (5.00%) 
Blood pressure increased  1  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/20 (5.00%) 
Nervous system disorders   
Disorientation  1  1/20 (5.00%) 
Dizziness  1  1/20 (5.00%) 
Headache  1  1/20 (5.00%) 
Renal and urinary disorders   
Pollakiuria  1  1/20 (5.00%) 
Reproductive system and breast disorders   
Endometrial hypertrophy  1  2/20 (10.00%) 
Menometrorrhagia  1  1/20 (5.00%) 
Skin and subcutaneous tissue disorders   
Urticaria  1  1/20 (5.00%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area, Head
Organization: Allergan
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02811159    
Other Study ID Numbers: ZPU-203EXT
First Submitted: June 21, 2016
First Posted: June 23, 2016
Results First Submitted: May 29, 2019
Results First Posted: June 19, 2019
Last Update Posted: June 27, 2019